New Jersey Administrative Code
Title 10 - HUMAN SERVICES
Chapter 167A - PROVISION OF PHARMACEUTICAL SERVICES UNDER THE PHARMACEUTICAL ASSISTANCE TO THE AGED AND DISABLED PROGRAM (PAAD)
Subchapter 1 - REQUIREMENTS FOR PROVISION OF PHARMACEUTICAL SERVICES
Section 10:167A-1.2 - Definitions
The following words and terms, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise:
"Active pharmaceutical ingredient" means any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient of the drug product.
"Annual income" means all income from whatever source derived, actually received or anticipated.
"Applicant" means an individual who applies or reapplies for PAAD, either personally or through an authorized agent.
"Beneficiary" means an individual who has been found eligible for PAAD benefits.
"Bulk drug substance" means a bulk drug substance as defined in 21 CFR 207.3(a)(4), that includes any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or finished dosage form of the drug. "Bulk drug substance" does not include intermediates used in the synthesis of such substances.
"Calendar year" means a year beginning January 1 and ending on December 31. It is the base period utilized to determine annual income and PAAD eligibility.
"Centers for Medicare and Medicaid Services (CMS)" means the agency of the Federal Department of Health and Human Services which is responsible for the administration of the Medicare program in the United States. CMS was formerly known as the Health Care Financing Administration (HCFA).
"Commissioner" means the Commissioner of the Department of Human Services.
"Current year" means the calendar year in which a person applies or reapplies for PAAD.
"Department" means the Department of Human Services.
"Division" or "DMAHS" means the Division of Medical Assistance and Health Services in the New Jersey Department of Human Services.
"Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)" means a type of Medicare Part B coverage that applies to certain types of medical equipment and supplies. Pharmacies enrolling as Medicare Part B suppliers for the purpose of PAAD's Medicare Recovery initiative must enroll under DMEPOS.
"Electronic Data Interchange (EDI) Enrollment Form" means an agreement signed by a Medicare Part B Supplier authorizing PAAD to bill Medicare electronically on its behalf for claims that are eligible under both PAAD and Medicare.
"Electronic Media Claim" or "EMC" means an electronic media claim processed by the State's fiscal agent, including claims submitted as real-time claims via modem or electronic bulletin board through the World Wide Web (www), in an electronic format that complies with the standards of the National Council on Prescription Drug Plans (NCPDP), DCPDP D.0/1.2 Payer Sheet, version D.0, which is incorporated herein by reference, as amended and supplemented. The NCPDP standards can be obtained from the NCPDP at 9240 East Raintree Drive, Scottsdale, Arizona 85260-7516, or by accessing the Pharmacy NCPDP-HIPAA Payer Sheet at http://www.njmmis.com/downloadDocuments/NJ_D-0_NCPDP_Payer_Sheet.pdf.
"Excipient" means an ingredient that does not contribute therapeutically to a compound, including, but not limited to, fillers, diluents, wetting agents, solvents, emulsifiers, preservatives, flavors, absorption enhancers, sustained-release matrices, and coloring agents.
"Expiration date" means the date when a beneficiary's PAAD eligibility ends.
"Initial Prescription Claim" means a PAAD claim for a drug not previously paid by the State during the 200-day calendar period immediately preceding the service date of a claim being considered for payment; or a PAAD claim that exceeds a time period based on the service date of the previously paid PAAD claim.
"Interchangeable drug product" means those drug products, with therapeutic equivalence ratings of "A," identified in the publication of the Office of Generic Drugs in the Office of Pharmaceutical Science of the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA) of the United States Department of Health and Human Services, Approved Drug Products with Therapeutic Equivalence Evaluations, 34th Edition, incorporated herein by reference, as amended and supplemented, commonly known as the "Orange Book," promulgated pursuant to the Federal Food, Drug, and Cosmetic Act, at 21 U.S.C. § 355(j)(7); and those drug products approved by the FDA with therapeutic equivalence ratings of "A" that appear on the FDA's "Drugs@FDA" website, bearing formal internet address http://www.accessdata.fda.gov/scripts/cder/drugsatfda/, incorporated herein by reference, as amended and supplemented. The Orange Book can be obtained by contacting the United States Government Printing Office at PO Box 979050, St. Louis, MO 63197, or at (866) 512-1800, or it is available on-line at http://www.accessdata.fda.gov/scripts/cder/ob/.
"Legend drug" means any approved drug product which by Federal law cannot be dispensed without a prescription and bears the statement on the label: "Caution: Federal law prohibits dispensing without a prescription."
"Medicare" means medical assistance provided to certain aged and disabled persons as authorized under Title XVIII (Medicare) of the Social Security Act.
"Medicare Part B Supplier" means a supplier of Medicare Part B (Medical Insurance) services to Medicare beneficiaries including Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS).
"Medicare Prescription Drug Program" or "Medicare Part D" means the prescription drug coverage program established under the Federal Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. 108-173 ( 42 U.S.C. § 1395w-101 et seq.)
"National drug code" or "NDC" means the three-segment identification number for a specific drug product issued by the U.S. Food and Drug Administration pursuant to 21 U.S.C. § 360 of the Federal Food, Drug and Cosmetic Act.
"National Provider Identifier" or "NPI" means a national identifier issued to a healthcare provider by the National Plan and Provider Enumeration System (NPPES) established pursuant to 45 CFR Part 162, Subpart D.
"National Supplier Clearinghouse (NSC)" means the entity that issues Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) supplier authorization numbers nationwide to Medicare Part B Suppliers for the Centers for Medicare and Medicaid Services (CMS). The National Supplier Clearinghouse is located at P.O. Box 100142, Columbia, SC 29202-3142.
"NSC Supplier Number" means the authorization number issued by the National Supplier Clearinghouse (NSC) to a Medicare Part B Supplier of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) for the Centers for Medicare and Medicaid Services (CMS).
"Pharmacy" means any pharmacy located in New Jersey, operating under a valid permit from the Board of Pharmacy of the State of New Jersey, which has filed an application and agreement of participation, which has been approved by the New Jersey Medicaid Program. The term "pharmacy" also includes any volunteer prescription drug mail-order program or specialty pharmacy in a Medicare Part D plan provider network or a mail order prescription drug program required by a PAAD beneficiary's primary payer.
"Prescription drugs" means all approved legend drugs, including any interchangeable drug products and in conformance with the provisions of the "Prescription Drug Price and Quality Stabilization Act," and insulin, insulin syringes, and insulin needles when prescribed.
1. The term "prescription drugs" includes:
i. Any drug product which by Federal law cannot be dispensed unless ordered by a physician, dentist or podiatrist;
ii. Every product considered to be a legend prescription drug;
iii. Insulin, insulin syringes and insulin needles. While not legend drugs, these items are covered by this program when prescribed; and
iv. Syringes and needles for injectable medicines.
2. The term "prescription drugs" excludes cosmetic drugs as indicated at 10:167A-1.15 unless medically necessary.
"Previous year" means the calendar year preceding the year in which the person is applying or reapplying for PAAD. For example, 1995 is the "previous year" when referring to an application which is dated between January 1, 1996 through December 31, 1996, inclusive.
1. If a person, who is required to submit a Federal, State and/or City Income Tax return, applies for PAAD at the beginning of a calendar year but has not yet filed an income tax return for the previous year, the last year for which the person filed a tax return is considered to be the "previous year" when completing the PAAD application.
"Provider" means any individual, partnership, association, corporation, institution, or any other public or private entity, agency, or business concern, meeting applicable requirements and standards for participation in the New Jersey Medicaid Program, and the Pharmaceutical Assistance to the Aged and Disabled Program, and where applicable, holding a current valid license, and lawfully providing medical care, services, goods and supplies authorized under 30:4D-1 et seq. and amendments thereto.
"Refill Prescription Claim" means a PAAD claim for a previously paid prescription in which the time period between claims is less than or equal to two times the days supply reported by the previously paid PAAD claim for the same prescription. A refill prescription claim may have the same or different prescription number.
"Resident" means "one legally domiciled within the State (of NJ) for a period of 30 days immediately preceding the date of application for inclusion in the PAAD Program. Mere seasonal or temporary residence within the State, of whatever duration, does not constitute domicile." (See 10:167-6.4 for residence requirements.)
